Class 2 Device Recall BD Nexiva 20 GA 1.00 (1.1 x 25mm) Dual Port

• Date Initiated by Firm: September 08, 2021
• Create Date: November 24, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0306-2022
• Recall Event ID: 88762
• 510(K)Number: K183399
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• Product: BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD Instaflash Needle Technology; Rx Only, Sterile EO. BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon" catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, dual port adapter, vent plug and pre-attached BD Q-Syte Luer Access Split Septum. The needle and catheter are protected by a needle cover. A BD Q-Syte device or an end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices have BD Instaflash" Needle Technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and dual port adapter are color coded to indicate catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green). BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.
• Code Information: Catalog number/Model number: 383536; Batch numbers/UDI numbers: Lot: 1193055/(17)240630(10)1193055(30)80/(01)50382903835367, 2024-06-30; Lot: 1166273: (17)240630(10)1166273(30)80/(01)50382903835367, 2024-06-30 Lot: 1166273: (17)240630(10)1166273(30)80/(01)50382903835367, 2024-06-30 Lot: 1188953: (17)240630(10)1188953(30)80/(01)50382903835367, 2024-06-30
• Recalling Firm/ Manufacturer: Becton Dickinson Infusion Therapy Systems Inc.; 9450 S State St; Sandy UT 84070-3213
• For Additional Information Contact: 801-565-2300
• Manufacturer Reason for Recall: There is a breach in the product packaging that renders the product non-sterile.
• FDA Determined Cause: Packaging process control
• Action: On September 30, 2021, the firm sent out a customer notification letter "Urgent Medical Device Recall" to their customers via Fed-Ex with the instruction due to the packaging breach, identified during the in house internal leak testing. This breach in the product packaging rendered the enclosed IV catheters non-sterile. Holes have been detected on the bottom tray of device unit packages. The notification stated to destroy the devices which are present in customers/distributors inventory. The recalling firm notified in a customer notification letter to fill and send the customer response form with customer's details and acknowledgement of destruction of the device list , lot number and quantities for the replacement. The contact information will be provided for the customers to call : 1-844-8BD-LIFE (1-844-823-5433)Say Recall when prompted, Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com The customer response form to be returned via: E-Mail BDRC17@bd.com, Fax No. is 312-949-0375.
• Quantity in Commerce: 155,840 devices, 80 units in each box
• Distribution: U.S. Nationwide Distribution: AR, AZ, MA, GA, NC, OH, WA, NY, NJ, HI, CA, MD, RI, MT, IN, PA, IL OK, OR, AK, CT, TX, ME, MO, FL, VA, LA, CO, UT O.U.S.: None
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FOZ